Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies
About
Brief Summary
The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-363, KITE-753, KITE-197, anitocabtagene autoleucel, INT2104, KITE-512, ACLX-001, and ACLX002 in participants of Kite-sponsored interventional studies.
The primary objectives of this study are to:
- Evaluate the incidence and severity of related SAEs, late-onset targeted AEs/SAEs suspected to be possibly related to gene-modified cell therapy, including neurologic disorders, new autoimmune disorders (which are distinct from the study-treated disease), hematologic disorders, serious infections, as well as any new malignancies (regardless of causality)
- Evaluate the growth, development, and sexual maturity of pediatric and adolescent participants treated with gene-modified cell therapy.
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- The individual must have been administered gene-modified cell therapy or completed the post-treatment follow-up period in the parent study, as applicable
- The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted
- In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation
Exclusion Criteria: none
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Enrolling by Invitation
These studies are not open to everyone who meets the eligibility criteria, but
only to people in that particular population, who are specifically invited to participate.
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Study Stats
Protocol No.
22-000859
Category
Adolescent & Young Adults (AYA)
Lymphoma
Multiple Myeloma
Principal Investigator
Location
- UCLA Santa Monica
- UCLA Westwood